Regulatory Letter definition

Regulatory Letter means a letter characterized by the FDA as ----------------- a warning letter, a notice of adverse finding or a similar letter in which FDA or any other Medical Device Regulatory Agency expresses the opinion that violations of law have occurred.
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Regulatory Letter means regulatory action taken by the FDA in the form of a letter, pursuant to discovery of any major violation of the Food, Drug, and Cosmetic Act and other related rules and regulations.
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Regulatory Letter means corre­ spondence addressed to the manage­ ment of a firm from FDA, intended to effect prompt and complete correction of a violative and product and/or con­ dition. In the absence of responsive action, such correspondence is a direct prelude to the institution of judicial or administrative proceedings.
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Examples of Regulatory Letter in a sentence

  • EURAND shall provide RELIANT with immediate notification of its receipt of any of the following related to the manufacture, production or testing of Product: a copy of any list of observations (Form FD 483), Warning Letter, Information Letter, Regulatory Letter or the like issued by the FDA as well as provide RELIANT an opportunity to review any written response prior to submission to the issuing agency.

  • Seller is an insured depository institution pursuant to the provisions of the Federal Deposit Insurance Act, as amended, and, other than as set forth in the Cease and Desist Order, the Amended Order, the FDIC Resolution and the OTS Regulatory Letter, no act or default has occurred.

  • If required by any DOE requirement, promptly obtain and maintain a Regulatory Letter of Credit in compliance with all DOE requirements.

  • No FLAG Entity has received, nor to FLAG's Knowledge are there facts that would form the basis for the issuance of, a "Year 2000 Deficiency Notification Letter" (as such term is employed in the Federal Reserve's Supervision and Regulatory Letter No. SR 98-3 (SUP), dated March 4, 1998).

  • Upon request of any SBIC Lender, furnish to such SBIC Lender information requested by the SBA, including without limitation SBA Forms, properly completed and duly executed and/or certified by an Authorized Officer of the Borrower, where applicable, and any information required pursuant to the SBIC Regulatory Letter.

  • Under the terms of the Regulatory Letter, the scale of outstanding loan of the Target Company’s business should maintain at similar level prior to the obtaining of the License.

  • No FLAG Entity has received, nor to FLAG 's Knowledge are there facts that would form the basis for the issuance of, a "Year 2000 Deficiency Notification Letter" (as such term is employed in the Federal Reserve's Supervision and Regulatory Letter No. SR 98-3 (SUP), dated March 4, 1998).

  • No HOGANSVILLE Entity has received, nor to HOGANSVILLE's Knowledge are there facts that would form the basis for the issuance of, a "Year 2000 Deficiency Notification Letter" (as such term is employed in the Federal Reserve's Supervision and Regulatory Letter No. SR 98-3 (SUP), dated March 4, 1998).

  • Neither Fifth Third nor any of its subsidiaries has received, nor to the knowledge of Fifth Third are there facts that would reasonably be expected to form the basis for the issuance of, a "Year 2000 Deficiency Notification Letter" (as such term is employed in the Federal Reserve's Supervision and Regulatory Letter No. SR 98-3 (SUP), dated March 4, 1998).

  • Neither the Company nor any of its Subsidiaries has received, nor to its knowledge are there facts that would reasonably be expected to form the basis for the issuance of, a "Year 2000 Deficiency Notification Letter" (as such term is employed in the Federal Reserve Supervision and Regulatory Letter No. SR 98-3 (SUP), dated March 4, 1998) or similar notice from any state banking authority.